LANTISEPTIC BY DERMARITE DRY SKIN THERAPY- lanolin cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H)

Available from:

Dermarite Industries LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Temporarily protects minor cuts, scrapes, and burns. Helps prevent and temporarily protects chafed, chapped or cracked skin.

Authorization status:

OTC monograph final

Summary of Product characteristics

LANTISEPTIC BY DERMARITE DRY SKIN THERAPY- LANOLIN CREAM
DERMARITE INDUSTRIES LLC
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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LANTISEPTIC BY DERMARITE DRY SKIN THERAPY
_ACTIVE INGREDIENT_
Lanolin USP 30%
_PURPOSE_
Skin Protectant
_USES_
Temporarily protects minor cuts, scrapes, and burns.
Helps prevent and temporarily protects chafed, chapped or cracked
skin.
_WARNINGS_
• FOR EXTERNAL USE ONLY.
• AVOID CONTACT WITH EYES. In case of contact, flush thoroughly with
water
DO NOT USE ON
Deep or puncture wounds
animal bites
serious burns
STOP USE AND ASK A DOCTOR IF
condition worsens
symptoms last more than 7 days or clear up and occur again within a
few days
KEEP OUR OF REACH OF CHILDREN. In case of accidental ingestion contact
a physician or Poision Control
Center right away.
KEEP OUT OF REACH OF CHILDREN.
_DIRECTIONS_
Apply liberally to affected area as needed or as directed by a
physician.
_OTHER INFORMATION_
Store at room temperature (59-86°F)
You may report a serious adverse event to DermaRite Industries, PO Box
7209, North Bergen, NJ
07047.
_INACTIVE INGREDIENTS_
Water, Mineral Oil, Petrolatum, Cera Alba, Sodium Borate, DMDM
Hydantoin, Sorbitan Sesquioleate,
Lanolin Alcohol, Disodium EDTA.
QUESTIONS OR COMMENTS?
Call 1-800-337-6296 Mon-Fri 9AM-5PM EST
PACKAGE LABELING:
Dermarite Industries LLC
LANTISEPTIC BY DERMARITE DRY SKIN THERAPY
lanolin cream
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 19 24-50 4
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
LANO LIN (UNII: 7EV6 5EAW6 H) (LANOLIN - UNII:7EV6 5EAW6 H)
LANOLIN
30 0 mg in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
PHENO XYETHANO L (UNII: HIE49 2ZZ3T)
YELLO W WAX (UNII: 2ZA36 H0 S2V)
CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)
EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)
LANO LIN ALCO HO LS